The US Department of Health and Human Services announced last week that the Food and Drug Administration would not require laboratory-developed tests to undergo premarket review, as GenomeWeb reported The New York Times notes the move appears to be motivated by the COVID-19 pandemic. In the announcement, HHS said CLIA-certified labs could offer tests they…
FDA Commissioner Stephen Hahn’s decisions and comments about granting Emergency Use Authorization for convalescent plasma to treat COVID-19 have put politics ahead of science, former senior FDA officials told BioCentury. “At this moment in time, the FDA can no longer call itself an independent and science-based regulatory agency,” Luciana Borio, former acting FDA chief scientist,…
The Trump administration this week ordered the Food and Drug Administration to allow the use of a certain class of laboratory tests, including some for the coronavirus, without first confirming that they work. For months some F.D.A. officials have worried that the pandemic would provide an opening for clinics, academic institutions and commercial labs to…
Patients living with HIV (PLWH) must take daily medications to suppress the virus, despite significant advancements in antiretroviral therapy (ART). A major limitation of ART is that it is only effective against an actively replicating virus. Therefore, despite being successful in suppressing HIV RNA, ART cannot inhibit a nonreplicating virus. The latter is a contributing…
Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using historical clinical trial data and real-world data in external control arms for single-arm trials, as well as the associated challenges.…
FDA is using real-world data to better understand and answer questions about potential COVID-19 therapies, and remdesivir is the next therapy in the spotlight. Through its real-world evidence public-private partnership, the COVID-19 Evidence Accelerator, the agency and its partners assessed hydroxychloroquine, and the partnership soon will apply a similar set of questions and analyses to…
COVID-19 has continued to bring diversity and health inequality to the forefront of people’s attention. Our latest round-up covers the July news around these issues, and brings you the latest initiatives that are trying to create positive change. Genentech make effort to boost diversity and inclusion in COVID-19 treatment studies The COVID-19 pandemic has exposed…
Abstract: Health professionals agree that increasing diversity in clinical trial participants is an important way to improve cancer care and address disparities in outcomes. However, trial participation among minority populations has been low historically and continues to be low. Underrepresentation has resulted in majority groups reaping greater benefit from research findings, thus widening cancer health…
In prepared witness testimony, leaders of the nation’s three top agencies battling the coronavirus outbreak describe their months-long efforts to develop testing, treatments and possible vaccines to control the pandemic. The statements come as the U.S. has recorded nearly 4.5 million total infections and more than 151,000 deaths — figures that most experts agree undercount…
The FDA’s Oncology Center of Excellence and Syapse presented data at the American Association of Clinical Research COVID-19 and Cancer meeting on an analysis of more than 212,000 health records of people living with cancer across two major health systems in the Midwestern United States. The analysis found that cancer patients who also had COVID-19…
